Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients

Age Related Macular Degeneration Clinical Trial

— UU2  

Official title:

Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748384
• Other study ID #: HMP-UU2
• Status: Completed
• Phase: N/A
• First received: September 4, 2008
• Last updated: May 14, 2013
• Start date: February 2009
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Description:

Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Capable and willing to sign a consent form and participate in the study

• Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded)

• Age more than 50 years

• VA with habitual correction better than 20/60 in the study eye

• Ability to speak, read and understand instructions in English or Hebrew

• Familiar with computer usage

Exclusion Criteria:

• Evidence of macular disease other than AMD or glaucoma in the study eye

• Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.

• Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

• Never been tested on the PHP device

• Participation in another study with the exclusion of AREDS study

• Patients diagnosed with geographic atrophy (GA)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Kaplan Medical Center	Rechovot

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who managed to set the device		6 months	No
Primary	Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training		6 month	No
Primary	Number of device malfunctions		6 month	No
Primary	Average use of the device		6 month	No

External Links

•   sponsor site